Investigation of Specific Protein/Markers in Patients With Osteoarthritis of the Knee Having a Total Knee Replacement
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|ClinicalTrials.gov Identifier: NCT01611441|
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : June 27, 2012
|Condition or disease|
|Osteoarthritis of the Knee|
|Study Type :||Observational|
|Actual Enrollment :||125 participants|
|Official Title:||Investigation of Biomarkers in an Exploratory Study in Patients With Osteoarthritis of the Knee Undergoing Total Knee Replacement Surgery|
|Study Start Date :||December 2011|
|Primary Completion Date :||June 2012|
|Study Completion Date :||June 2012|
Patients with osteoarthritis of the knee
Patients with osteoarthritis of the knee undergoing total knee replacement surgery.
- Proportion of patients with upregulation of IL-6 or the IL-6 signalling pathway in the knee. [ Time Frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery) . ]
- Biomarkers in synovial fluid, synovial membrane, and cartilage. [ Time Frame: Day 1 (surgery). ]
- Biomarkers in blood and urine. [ Time Frame: 3-20 days prior to day 1 (surgery) and day 1 (surgery). ]
- Biomarkers by Magnetic Resonance Imaging (MRI). [ Time Frame: 1-5 days prior to day 1 (surgery). ]
- Polymorphisms in 10 specific genes. [ Time Frame: 3-20 days prior to day 1 (surgery) or at any time in the study. ]
- WOMAC (Western Ontario and McMaster Osteoarthritis Index) variables and NPQ (Neuropathic Pain Questionnaire) variables. [ Time Frame: 3-20 days prior to day 1 (surgery) and 1-5 days prior to day 1 (surgery). ]
WOMAC consists of 3 subscales with a total of 24 questions regarding pain, stiffness and difficulty in performing daily activities. A VAS (Visual Analogue Scale) will be used for the patient to report the severity of the symptoms on the target knee. Endpoints are marked "No pain" (0 mm) and " Extreme pain" (100 mm) on a paper PRO (Patient Reported Outcome) questionnaire. The less pain scored the better outcome.
NPQ accesses 12 different pain intensities. 0 represents no intensity and 100 represents worst intensity imaginable. The less intensity the better outcome.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611441
|Study Director:||Rolf Karlsten, MD, PHD||AstraZeneca R&D Sodertalje, Sweden|